Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)

NCT06293300 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20231056HT94252310608
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Change in photophobia measured by Numerical Rating Scale

  The change in numerical rating of average photophobia during the past week, ranging from 0 (for "no ocular pain") to 10 ("the most intense ocular pain imaginable").

  Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

• Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)

  The change in the OPA visual photosensitivity thresholds, ranging from 0 to 4.51 log lux, with a lower VPT indicating less tolerance to light or increased light sensitivity.

  Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

Secondary Outcomes (9)

• Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)

  Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

• Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye).

  Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

• Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25)

  Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

• Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)

  Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

• Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6

  Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

Study Arms (1)

BoNT-A Group

EXPERIMENTAL

Participants will receive BoNT-A intervention for up to 6 months.

Drug: BoNT A

Interventions

BoNT A DRUG

Participants with TBI-associated photophobia will come one time in person to the clinic and receive 35 Units of BoNT-A injected in 7 forehead sites (0.1 cc in each location).

BoNT-A Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
• ≥18 years of age who are able to consent.
• Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (\>1 year).
• Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
• English as primary language (by self-report).

You may not qualify if:

• Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.
• Patients who are participating in another study with an investigational drug within one month prior to screening.
• Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or \>12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan.

Sponsors & Collaborators

• University of Miami: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Anat Galor, MD/MSPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Galor, MD/MSPH

CONTACT

(305) 3266000; agalor@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)